August 20, 2003
Novartis Pharmaceuticals Has Recalled
Combipatch Transdermal System
The Food and Drug Administration (FDA) released the following information.
Combipatch Transdermal System, (estradiol/norethindrone acetate transdermal
system) 0.05/0.25 mg per day, 3 Patient Calendar Packs of 8 Systems, Rx
only. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover,
New Jersey Recall # D-304-3.
Lot Number: 61921011, Expiry 06-2004.
Recalling Firm: Novartis Pharmaceuticals, Corp, Suffern, NY, by letter on
July 3, 2003.
Manufactured by: Noven Pharmaceuticals, Inc., Miami, Florida. Firm initiated
recall is ongoing.
Subpotency (estradiol/NETA) and Degradation failure (excess primary
VOLUME OF PRODUCT IN COMMERCE